title: Determining the applicability of threshold of toxicological concern approaches to substances found in foods.
abstract: Threshold of Toxicological Concern (TTC) decision-support methods present a pragmatic approach to using data from well-characterized chemicals and protective estimates of exposure in a stepwise fashion to inform decisions regarding low-level exposures to chemicals for which few data exist. It is based on structural and functional categorizations of chemicals derived from decades of animal testing with a wide variety of chemicals. Expertise is required to use the TTC methods, and there are situations in which its use is clearly inappropriate or not currently supported. To facilitate proper use of the TTC, this paper describes issues to be considered by risk managers when faced with the situation of an unexpected substance in food. Case studies are provided to illustrate the implementation of these considerations, demonstrating the steps taken in deciding whether it would be appropriate to apply the TTC approach in each case. By appropriately applying the methods, employing the appropriate scientific expertise, and combining use with the conservative assumptions embedded within the derivation of the thresholds, the TTC can realize its potential to protect public health and to contribute to efficient use of resources in food safety risk management.
authors.affiliation: a Center for Risk Science Innovation and Application (RSIA) , ILSI Research Foundation , 1156 Fifteenth Street NW, Suite 200 , Washington , DC , 20005-1743 , USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Canady
authors.forename: Richard
authors.initials: R
authors.lastname: Lane
authors.forename: Greg
authors.initials: G
authors.lastname: Paoli
authors.forename: Margaret
authors.initials: M
authors.lastname: Wilson
authors.forename: Heidi
authors.initials: H
authors.lastname: Bialk
authors.forename: Steven
authors.initials: S
authors.lastname: Hermansky
authors.forename: Brent
authors.initials: B
authors.lastname: Kobielush
authors.forename: Ji-Eun
authors.initials: JE
authors.lastname: Lee
authors.forename: Craig
authors.initials: C
authors.lastname: Llewellyn
authors.forename: Joseph
authors.initials: J
authors.lastname: Scimeca
mesh_terms: D023401:Animal Use Alternatives / Q000379:methods*; D002273:Carcinogens / Q000737:chemistry / Q000633:toxicity; D005502:Food / Q000633:toxicity*; D005504:Food Analysis / Q000379:methods*; D006801:Humans; D019055:No-Observed-Adverse-Effect Level; D018570:Risk Assessment
chemical_list: D002273:Carcinogens